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Columbia Laboratories Confirms FDA Denies Watson's Appeal Related to Prochieve NDA for the Prevention of Preterm Birth

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Columbia Laboratories Inc. (Nasdaq: CBRX) today confirmed that the U.S. Food and Drug Administration (FDA) has denied Watson Pharmaceuticals' (NYSE: WPI) Formal Dispute Resolution Request (FDRR) related to its New Drug Application (NDA 22-139) for Prochieve for the prevention of preterm birth in women with a short cervical length. Watson said it intends to review possible options related to the continued pursuit of the NDA. Watson filed its FDRR in August of 2012.

Posted-In: News FDA

 

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